Climatic Chamber: Product Testing, Several Applications
Before marketing, in fact, the goods must pass a large number of tests, established both by the different laws from regulatory bodies, and by manufacturers themselves, to be able to confirm the features of what will be put on the market. For example, how do we make sure that an electronic device works at -40 °? Or, how do we determine the expiration date of a food, cosmetic or drug? Thanks to specific tests, possible through a climatic chamber.
Before being placed on the market, the goods must pass a large number of checks and tests, which are established both by the various laws in force of the regulatory bodies and by the manufacturers themselves, to confirm the characteristics of what will go on the market. For example, how can we be sure that an electronic device is working at -40°? Or, how do we determine the expiry date of a food, cosmetic or drug? Thanks to specific evidence, possible through a climate chamber.
Pharmaceutical Product Testing
Pharmaceutical products, cosmetics, building materials and food share a validation procedure called stability testing. Based on the relative application, the criteria defining each test are different and regulated by as many official bodies, which determine types and methods of testing.
Pharmaceuticals, cosmetics, building materials and products of the food industry share a validation procedure that is called stability test. Depending on the scope, of course, the criteria defining each test are different and regulated by as many official bodieswhich determine the types and methods of testing.
What Is Stability Testing
The Italian Official Pharmacopoeia thus defines the stability of pharmaceutical products. But what does pharmaceutical stability testing mean? Let us clarify that below.
The Official Italian Pharmacopoeia thus defines the stability of pharmaceutical products. But what stability testing means for the pharmaceutical sectorLet's clear up the next few lines.
developing a pharmaceutical good, defining its specifications
- develop a product pharmaceutical, defining its characteristics
- studying the feasibility of developing new API - Active Pharmaceutical Ingredients
- Study the feasibility of developing new active ingredients (API - Active Pharmaceutical Ingredient)
- manage the packaging (integrity of the packaging, consequences of the product coming into contact with the packaging)
Even during this last process, in fact, the properties of the FPP (finished pharmaceutical product) in question tend to change.
In summary, the final aim of stability testingis the determination of:
- review date (retest period)
- review date (retest period)
The retest period, or review date, is instead the period of time during which the pharmacological substance can be considered as falling within the predefined specifications and therefore still usable.
The retest period, o review dateis the period of time during which the pharmacological substance can be considered as falling within the predefined specifications and therefore still usable.
The stress test is a forced degradation test: it is not the real conditions that the product will face, but a planned deterioration that has the purpose of predicting any issues of the goods, to prevent them from intervening in the "official" life cycle of the product.
The stress test is a proof of forced degradationIt is not a question of the real conditions that the product will face, but of a scheduled deterioration which has the purpose of predicting possible problems of the goods, in order to prevent such inefficiencies from intervening in the "official" life cycle of the same.
The deterioration of the sample will be mathematically calculated from the relationship between the degradation of the product and the speed of the stress process.
Stress testing is not mandatory for all drugs. We recommend that you refer to the various official regulations to find out which goods are exempt.
Climatic Chamber for Stability Testing: How Does It Work?
What variables are involved in a climatic test for the pharmaceutical sector?
Temperature, humidity and, in some specific cases, illumination. These parameters are the three main ones that characterize a climatic chamber. How?
Controlled temperature and humidity must replicate the natural environmental compartments present in the air.
The stability testing requires constant and homogeneous both temperature and humidity, for the entire duration of the test and regardless of the load inside the device.
Humidity is also a fundamental variable to manage, same as temperature.
Themoisture is a key factor to control, at the same temperature level.
The pharmaceutical testing chambers are in fact equipped with a specific humidification device.
Also lighting is required to be homogeneous in the same way, both on the walls and on the shelves of the chamber
The ICH Q1A Stability Test
TheICHnamely theInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use defined the criteria for the stability test for pharmaceutical products through the Directive ICH Q1A (R2) - Stability testing of new drug substances and drug products.
It requires tests to be performed with the following temperature and humidity values:
25°C±2°C / 60% Rh±5%
30°C±2°C / 65% Rh±5%
40°C±2°C / 75% Rh±5%
25°C±2°C / 40% Rh±5%
30°C±2°C / 35% Rh±5%
40°C±2°C / 20% Rh±5%
FDM Pharmaceutical Testing Chambers
The FDM climatic chambers are the right choice for the ICH Q1A stability test, for all product tests for the pharmaceutical sector and for many other applications.
The manufacturer of climatic chambers must be able to provide a device with robust and high quality components, to ensure homogeneous temperature and humidity parameters.
FDM climatic chambers are the right choice for the stability test ICH Q1Afor the various product tests for the pharmaceutical sector and for many other fields of application.
High quality components and stainless steel interiors guarantee impenetrability to external agents and extreme ease of internal cleaning. The high-tech precision sensors with which we equip our chambers guarantee the right temperature and humidity parameters.